Clean Room Manufacturing OperatorH (Plainsboro)

Clean Room Manufacturing Operator

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

This Clean Room Manufacturing Operator role will include processes such as enzymatic treatment of collagen, alkali treatment of collagen, tendon collagen prep, dispersion preparation, and lyophilization. It is essential to perform these tasks meticulously to ensure the quality of our products.

Additionally, you will be responsible for the setup, operation, and cleaning of all clean room manufacturing equipment. This entails working in ISO Class 5 or ISO Class 7 areas and adhering to Clean Room gowning protocols. All operations must be conducted in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOPs), and Health and Safety requirements.

Operating in a team environment, we emphasize daily achievements and maintaining high-quality standards in our production processes. Your dedication and attention to detail will play a valuable role in our success.

Essential Duties And Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Operate, maintain, and troubleshoot process equipment utilized in the collagen business, and can make minor equipment adjustments as needed.

Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.

Blend, mix, pour, and load collagen prepped material into lyophilizing equipment.

Pass and maintain gowning qualification to perform Gowning Requirement for ISO Class 5 Clean Room operations or ISO Class 7 Clean Room operations.

Responsible for accurately maintaining legible and accurate records, required logs, books, and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP's), and Health and Safety requirements.

Interface with QA / QC / Material departments during course of work to coordinate inspections and efficient flow of subassemblies and completed product.

Enter and record production activities in Oracle MRP systems to issue material and labor hours to specific work orders.

Follow applicable Standard Operating Procedures, Quality System Regulations and ISO 13485 requirements.

Responsible for handling, decontamination, and cleaning of production supplies, instruments, and equipment to support all cleanroom production related activities.

Responsible for reporting all discrepancies to the Supervisor or Group Leader.

Support department and plant Safety goals by continuously demonstrating safe behavior.

Maintain a clean and orderly work area.

Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements.

Perform other manufacturing activities as assigned by the department leadership.

Desired Minimum Qualifications

The requirements listed below are representative of the knowledge, skill, and / or ability required for this position.

High School diploma or equivalent. Degree in related science a plus.

0 - 2 years of chemical processing experience or batch mixing in Medical Device or Pharmaceutical manufacturing industry. Production experience in a clean room environment is highly desirable.

Basic computer skills for email and data entry.

Must read, write and speak in English, and communicate clearly and concisely.

Fundamental understanding of mathematics and chemistry.

Able to participate in a team-oriented environment, willingness to assist and train others.

Able to work independently with minimal supervision.

Ability to operate, maintain and troubleshoot process equipment, and make minor adjustments as needed.

Ability to gown to ISO Class 5 and 7 Clean Room standards.

Able to work overtime.

Tools And Equipment Used

Lyophilizers, autoclave, homogenizers, grinder, vacuum pump, pH meters, thermometers, balances (scales), water bath circulators, sonicators, humidity cabinet, mixers, centrifuge, blenders, air gun, drop indicator, Filamatic filling machines, slicer machines, scalpels, temperature recorders, crosslinking chamber, humidification chamber, compression unit, cutting table, sealing machines, shrink wrap machines.

Physical Requirements

The physical requirements listed in this section include but are not limited to the motor / physical abilities and skills required of this position to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and write / type. The employee must be able to stand for 8 hours, lift up to 60lbs and climb ladders without assistance. The employee is required to go to all areas of the company.

Must be able to bend and lift 30 to 60 lbs without assistance on a daily basis.

Ability to gown to ISO Class 5 Clean Room standards and / or additional Clean room clothing.

Ability to gown to ISO Class 7 Clean Room standards and / or additional Clean room clothing.

Ability to stand for 8 hours.

Must be able to climb step ladders, without assistance.

Vision : Requires eye sight correctable to 20 / 25 to detect any defect in product / materials. Visual acuity adequate to perform job duties, including meeting all the quality reclassification. Requires normal color perception.